This is a randomised, open-label, multi-centre, Phase II study in patients with newly diagnosed glioblastoma. 62 patients with newly diagnosed glioblastoma are enrolled in the study in a 1:2 allocation (standard of care (SOC): ALECSAT as an adjunct therapy to SOC). Patients recruited into this study will receive either: * ALECSAT as an adjunct therapy to standard of care for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator's discretion) or * Standard of care therapy for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator's discretion).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
3 doses of ALECSAT/4 weeks followed by ALECSAT/3 months
Radiotherapy 5 days/week for 6 weeks
Temozolomide daily for 6 weeks followed by 6 cycles 5days/4weeks
Sahlgrenska University Hospital
Gothenburg, Sweden
Ryhov hospital
Jönköping, Sweden
Skånes university hospital
Lund, Sweden
Karolinska University hospital
Stockholm, Sweden
Progression Free Survival
Compare the progression free survival between patients who receive ALECSAT as add on to SoC and patients who only receive SoC
Time frame: 24 months after LPFV or when 47 patients has reached investigator assessed disease progression or death from any cause
Proportion of patients alive at 12 and 24 months
To compare OS rate at 12 and 24 months between patients who receive ALECSAT as add on to SoC and patients who only receive SoC
Time frame: 24 months after LPFV or when 47 patients has reached investigator assessed disease progression or death from any cause
Frequency and Severity of treatment related Adverse Events
Comparison of frequency and severity of treatment related AEs in the 2 study groups
Time frame: Up to 24 months after randomisation of last patient
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